VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR

Polymer Patient Examination Glove

ARISTA LATINDO INDUSTRIAL, LTD. P.T.

The following data is part of a premarket notification filed by Arista Latindo Industrial, Ltd. P.t. with the FDA for Vinyl Examination Gloves, Powder Free And Pink Color.

Pre-market Notification Details

Device IDK031944
510k NumberK031944
Device Name:VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
ClassificationPolymer Patient Examination Glove
Applicant ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta,  ID 11210
ContactLinga Sumarta
CorrespondentLinga Sumarta
ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta,  ID 11210
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-24
Decision Date2003-09-23

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